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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THERAKOS, INC. THERAKOS UVAR XTS SYSTEM

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THERAKOS, INC. THERAKOS UVAR XTS SYSTEM Back to Search Results
Model Number 6660
Device Problem Lens washers, failure of (1367)
Patient Problem Twitching (2172)
Event Date 01/28/2014
Event Type  malfunction  
Event Description
Customer called to report a blood leak that occurred during treatment.Name and function of complainant: same as reporter.Customer called to report blood leak during cycle 1.Customer stated there was a blood leak alarm and when the centrifuge chamber door was opened, there was blood leaking from the neck of the centrifuge bowl.Customer stopped the procedure without returning any blood/products to the patient.Css asked customer if there were any alarms prior to the blood leak alarm.Customer states there were multiple empty a/c alarms.Css asked if there was any clotting or occlusions observed in the kit when it was removed.Customer stated there was no clotting or any occlusions in the kit.Css asked if patient was stable, and customer stated patient was stable and asymptomatic.They were able to start another procedure on this patient.No kit was returned for investigation.
 
Manufacturer Narrative
Batch record review of lot a908 was conducted.There were no non-conformities related to this type of failure for this lot.Lot met release requirements.Trends have been reviewed on a lot by lot basis for this complaint category and no trend has been detected for this specific lot.The assessment is based on information available at the time of the investigation.No product was returned by customer for investigation; therefore, no root cause could be determined at this time.Complaints of this nature are monitored through tracking and trending.Should a trend arise, further action will be taken.
 
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Brand Name
THERAKOS UVAR XTS SYSTEM
Type of Device
XTS
Manufacturer (Section D)
THERAKOS, INC.
bridgewater NJ
Manufacturer (Section G)
HARMAC MEDICAL PRODUCTS
2201 bailey ave
buffalo NY 14211
Manufacturer Contact
440 us route 22 east ste 140
bridgewater, NJ 08807
9083675452
MDR Report Key3824068
MDR Text Key4400790
Report Number2523595-2014-00048
Device Sequence Number1
Product Code LNR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P680003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/01/2017
Device Model Number6660
Device Lot NumberA908 KIT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/28/2014
Initial Date FDA Received02/21/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age46 YR
Patient Weight186
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